Radiofrequency Device Approved for Severe Chronic Asthma
Helps control lung inflammation
WEDNESDAY, April 28, 2010 (HealthDay News) -- The first device that uses radiofrequency energy to help control lung inflammation in adults with severe chronic asthma has been approved by the U.S. Food and Drug Administration.
The Alair Bronchial Thermoplasty System is designed for people 18 and older whose asthma isn't controlled with medication, including inhaled corticosteroids or long-acting beta agonists.
The device delivers radiofrequency energy directly to the airways, heating and reducing the thickness of lung tissue and improving users' ability to breathe, the agency said in a news release.
To achieve the device's full benefit, users will require multiple sessions targeting different parts of the lungs.
The device was evaluated in a clinical study involving 297 people with severe and persistent asthma. As a condition of approval, California-based manufacturer Asthmatx Inc. must conduct additional studies to evaluate the product's long-term safety and effectiveness, the FDA said.
Potential side effects include asthma attacks, wheezing, chest pain or tightness, partially collapsed lung, coughing up blood, anxiety, headache or nausea.
The device should not be used by people with an implanted pacemaker or defibrillator, the agency said.
The FDA has more about this approval.